Not provided
Not provided
Not provided
Not provided
Difficulty with inclusion, demotivation of centers in general
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.
Two ARM are compared in this study:
Patients are randomized to receive in cross-over 2 ARM: CPAP and Extended Sigh (eSigh). The following data: oxygen tissue partial pressure (PtiO2), respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alveolar recruitment maneuvers Group 1 | Experimental | alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh |
|
| Alveolar recruitment maneuvers Group 2 | Experimental | alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alveolar recruitment maneuvers group 1 | Other | Patients are randomized to receive in cross-over 2 ARM: CPAP at first and then eSigh. The continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume. The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cmH2O with decrease of tidal volume (Vt) if necessary. The following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of oxygen tissue partial pressure (PtiO2) values | The comparison of PtiO2 values (mmHg, mean ± SD) 60 minutes after the 2 ARM: eSigh and CPAP | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of systemic hemodynamic parameters | Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output. | 60 minutes |
| Comparison of Intracranial hemodynamic parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ségolène MROZEK, MD | UH TOULOUSE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Toulouse | Toulouse | Midi Pyrénées | 31059 | France | ||
| UH Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18416847 | Background | Constantin JM, Jaber S, Futier E, Cayot-Constantin S, Verny-Pic M, Jung B, Bailly A, Guerin R, Bazin JE. Respiratory effects of different recruitment maneuvers in acute respiratory distress syndrome. Crit Care. 2008;12(2):R50. doi: 10.1186/cc6869. Epub 2008 Apr 16. | |
| 18514825 | Background | Rangel-Castilla L, Gopinath S, Robertson CS. Management of intracranial hypertension. Neurol Clin. 2008 May;26(2):521-41, x. doi: 10.1016/j.ncl.2008.02.003. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| alveolar recruitment maneuvers group 2 | Other | Patients are randomized to receive in cross-over 2 ARM: eSigh at first and then CPAP. The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cmH2O with decrease of tidal volume (Vt) if necessary. The continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume. The following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM. |
|
Comparison between the two ARM of Intracranial hemodynamic parameters: ICP (Intracranial pressure) , cerebral perfusion pressure and Transcranial Doppler (pulsatility index, mean, systolic and diastolic velocities)
| 60 minutes |
| Comparison of blood oxygen level | Comparison between the two ARM of haematosis: Blood oxygen level (SpO2) | 60 minutes |
| Comparison of partial pressure of carbon dioxide | Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2), | 60 minutes |
| Comparison of arterial blood gases | Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2), | 60 minutes |
| Comparison of end-tidal CO2 | Comparison between the two ARM of end-tidal CO2 | 60 minutes |
| Comparison of Respiratory parameters | Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance. | 60 minutes |
| Comparison of PtiO2 | Comparison between the two ARM of PtiO2 | 60 minutes |
| Caen |
| 140033 |
| France |
| UH Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| UH Montpellier | Montpellier | 34295 | France |
| UH Nantes | Nantes | 44093 | France |
| 17127126 | Background | Chesnut RM. Care of central nervous system injuries. Surg Clin North Am. 2007 Feb;87(1):119-56, vii. doi: 10.1016/j.suc.2006.09.018. |
| 20197533 | Background | Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218. |